Regulatory information – new formatted table template to be used in selected veterinary procedural submission cover letters
The European Medicines Agency has published a new formatted table template that all companies need to insert in the cover letters of selected applications for veterinary medicines from now on. The table should be inserted in the cover letters of the applications in the following procedures:
- initial marketing authorisations;
- maximum residue limits (MRL) applications.
Marketing-authorisation holders should use the table template in all procedure-related submissions, including re-submissions of amended applications as well as submissions of responses at various stages of the above-mentioned procedures.
The formatted table template is intended to systematically structure and label key information concerning the procedure in a comprehensive summary. It is accompanied by explanatory notes.
As observed with applications for medicines for human use, this new table template should streamline the administrative process both for the Agency and the applicant.
Applicants are welcome to provide their feedback on the use of the table to firstname.lastname@example.org.